Pfizer Recalls Oxbryta: Sickle Cell Patients File Lawsuits
Photo Credit: Unsplash | Published: January 1, 2025
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What's the Pfizer Sickle Cell Oxbryta Recall and Lawsuit?
Oxbryta, a drug initially hailed as a breakthrough for sickle cell disease treatment, was voluntarily withdrawn from the market by Pfizer in 2024. Post-marketing clinical trials revealed that the drug's benefits no longer outweighed the risks, with a higher rate of vaso-occlusive crises (also known as "VOC's") and deaths among patients taking Oxbryta compared to those receiving a placebo. This discovery led to Pfizer's decision to halt distribution and discontinue all clinical trials, and the FDA recommending that healthcare professionals stop prescribing the drug.
The recall has sparked numerous lawsuits against Pfizer, alleging that the company failed to adequately investigate and disclose the drug's potential risks. Patients who experienced severe side effects, including VOCs, strokes, severe pain, and death, may be eligible to join these lawsuits. The FDA is conducting a safety review and will communicate any additional findings. Meanwhile, patients who were taking Oxbryta are advised to consult with their doctors to discuss alternative treatment options.
What is Pfizer Oxbryta?
Oxbryta (voxelotor), launched in 2019, was initially hailed as a promising treatment for sickle cell anemia, a genetic blood disorder causing red blood cells to deform and obstruct blood flow, leading to severe pain and organ damage. The drug's approval by the FDA was expedited due to its potential to address a significant unmet medical need.
Safety Concerns and Recall
However, in 2024, Pfizer, the company that acquired Oxbryta's developer, Global Blood Therapeutics, announced a voluntary recall of the drug. This decision followed reports of severe side effects, including vaso-occlusive crises (VOCs), strokes, and even fatalities in some patients.
Legal Action Over Pfizer Oxbryta Recall
The recall has triggered numerous lawsuits against Pfizer. The lawsuits allege that the manufacturers were aware of or should have been aware of the drug's potential risks but failed to adequately investigate or disclose them.
Individuals prescribed Oxbryta for sickle cell disease and subsequently experienced severe complications like VOCs, strokes, severe pain, or death may be eligible for any pending litigation to recover potential damages.
What Was the FDA's Response?
The FDA (The U.S. Food and Drug Administration), which initially approved Oxbryta under an accelerated pathway, conducted a safety review of post-marketing data. The review revealed a higher rate of VOCs and deaths among patients taking Oxbryta compared to those receiving a placebo. Based on these findings, the FDA recommended that healthcare professionals stop prescribing Oxbryta and that patients discuss alternative treatments with their doctors.
What Has Pfizer's Response Been to the Oxbryta Fallout?
In response to the safety concerns, Pfizer not only withdrew Oxbryta from the market but also halted all ongoing clinical trials and expanded access programs for the drug. The company stated that its decision was based on a comprehensive review of clinical data, which indicated that the benefits of Oxbryta no longer outweighed the risks for sickle cell patients.
What is the Total Settlement Amount?
As there is no class action lawsuit settlement as of May 2025.
How Do I Qualify For a Payout?
To qualify in any potential lawsuits or class action settlements, it is anticipated that affected individuals must have been prescribed Oxbryta for sickle cell disease and developed severe complications such as VOCs, strokes, or death.
How Do I Find Class Action Settlements?
Find all the latest class actions you can qualify for by getting notified of new lawsuits as soon as they are open to claims:
How Much Can I Get Paid?
In any class action lawsuit or settlement with Pfizer over Oxbryta, the payout amount is anticipated to vary widely based on the severity of complications, such as any related hospitalizations, and lasting organ damage.
How Do I File a Claim?
Many individual law firms and lawyers are investigating Oxbryta lawsuit settlements nationwide. This suggests that individual lawsuits are being pursued. Contact a law firm specializing in product liability or medical and healthcare cases to file a claim. Gather necessary evidence, including medical records, prescription records, and documentation of severe complications.
What Else Should I Do Next if I Took Oxbryta?
Patients who were taking Oxbryta should promptly consult with their healthcare providers to explore alternative treatment options. Those who experienced severe side effects while on Oxbryta may consider seeking legal counsel to understand their options regarding potential lawsuits. The FDA continues to monitor the situation and may communicate additional findings as they become available.
Claim Form Website: Pending
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